Info & Opinion
May 23, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Drexel University's College of Medicine selected the clinical trial management system (CTMS) of Study Manager. “We sought a CTMS that would help centralize clinical trial data and research processes,” said Donna Walsh, COO of clinical research at Drexel. “Our hope is that the CTMS database will help us move away from dependency on traditional methods of data processing.” The CTMS has functions to help track trial budgets and bill participating patients correctly.
DecisionView, a San Francisco patient recruitment software firm, has updated its flagship program. There are attractive screenshots of the system here and here, highlighting new features for assessing site and country performance. "StudyOptimizer has quickly become a trusted ‘source of truth’ for our customers because it provides up-to-date information about where trial enrollment is, where it’s supposed to be, and where it will end up—all in one place," said Linda Drumright, DecisionView's president and CEO.
The insightful blog of Assero, David Iberson-Hurst's clinical trial IT consultancy, has wonderfulk commentary. For the record, the FDA is still not requiring the usage of data guidelines in the submission process. That's not even on the horizon in a federal government run by childlike politicians. Rather, the government is nagging the industry to use third-party guidelines and threatening that review intervals will be longer for those who prefer the old-fashioned, paper-based techniques. But if you read between the lines, the IT geeks at FDA are coming close to expressing frustration that the term "standard" has proven to be meaningless. "CDER has observed significant variability in submissions containing 'standardized' electronic clinical trial data," quoth this one-page FDA document. Our translation: a clinical data "standard" can mean just about anything, including a ham sandwich.
United Biosource, part of Medco, could become part of Express Scripts, a big firm that helps companies minimize pharmacy costs. But some analysts doubt a merger of Medco and Express Scripts will survive antitrust scrutiny, as it involves two of the largest such firms joining forces.
Icon released quarterly financial results. Net service revenue rose four percent, to $233 million. Profits fell 43 percent, to $13 million. The results suggest a slackening pace of research across the industry. During the period, Icon did sign up Pfizer for a two-year deal in which many trials will be divided between it and another CRO, Parexel. "We are thus increasing our hiring drive and expect to add significant cost in the next two quarters as we gear up to handle work which will be transitioned to us in Q4 and throughout 2012," Icon said. Wall Street analysts are skeptical. They're questioning the profitability of much-trumpeted strategic deals because the sponsor community appears to be able to consistently negotiate such heavily discounted terms for massive numbers of trials.